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510(k) K142199

Ascendra Balloon Aortic Valvaloplasty Catheter by Edwards Lifesciences — Product Code OZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2014
Date Received
August 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon Aortic Valvuloplasty
Device Class
Class II
Regulation Number
870.1255
Review Panel
CV
Submission Type

A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.

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Other clearances for product code OZT

  • K241562 — OutFlo Aortic Valve Dilatation Balloon Catheter (March 11, 2025)
  • K240967 — ValvuloPro Valvuloplasty Balloon Catheter (July 31, 2024)
  • K231814 — ValvuloPro Valvuloplasty Balloon Catheter (October 12, 2023)
  • K220881 — INOUE BALLOON A (December 18, 2022)
  • K172932 — True Flow Valvuloplasty Perfusion Catheter (December 13, 2017)
  • K152613 — True Flow Valvuloplasty Perfusion Catheter (January 19, 2016)
  • K152150 — V8 Balloon Aortic Valvuloplasty Catheter (December 18, 2015)
  • K150667 — True Dilatation Balloon Valvuloplasty Catheter (June 17, 2015)
  • K142083 — TRUE FLOW VALVULOPLASTY PERFUSION CATHETER (April 17, 2015)
  • K150343 — V8 Transluminal BAV Catheter (April 3, 2015)